NDC 54348-550

Amoxicillin

Amoxicillin

Amoxicillin is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Amoxicillin.

Product ID54348-550_8f76596c-8fb7-7660-e053-2995a90aff34
NDC54348-550
Product TypeHuman Prescription Drug
Proprietary NameAmoxicillin
Generic NameAmoxicillin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-07-12
Marketing CategoryANDA / ANDA
Application NumberANDA064076
Labeler NamePharmPak, Inc.
Substance NameAMOXICILLIN
Active Ingredient Strength500 mg/1
Pharm ClassesPenicillin-class Antibacterial [EPC],Penicillins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-550-21

1 BOTTLE in 1 BOX (54348-550-21) > 21 CAPSULE in 1 BOTTLE
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-550-30 [54348055030]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA064076
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

NDC 54348-550-21 [54348055021]

Amoxicillin CAPSULE
Marketing CategoryANDA
Application NumberANDA064076
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-12

Drug Details

Active Ingredients

IngredientStrength
AMOXICILLIN500 mg/1

OpenFDA Data

SPL SET ID:a39fb9d2-4fd4-4a90-aec1-6acaf35ba2e9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308191
  • Pharmacological Class

    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]
    • Penicillin-class Antibacterial [EPC]
    • Penicillins [CS]

    NDC Crossover Matching brand name "Amoxicillin" or generic name "Amoxicillin"

    NDCBrand NameGeneric Name
    0093-2263AmoxicillinAmoxicillin
    0093-2264AmoxicillinAmoxicillin
    0093-2267AmoxicillinAmoxicillin
    0093-2268AmoxicillinAmoxicillin
    0093-3107AmoxicillinAmoxicillin
    0093-3109AmoxicillinAmoxicillin
    0093-4150AmoxicillinAmoxicillin
    0093-4155AmoxicillinAmoxicillin
    0093-4160AmoxicillinAmoxicillin
    0093-4161AmoxicillinAmoxicillin
    0143-9285AmoxicillinAmoxicillin
    0143-9820AmoxicillinAmoxicillin
    0143-9821AmoxicillinAmoxicillin
    0143-9886AmoxicillinAmoxicillin
    0143-9887AmoxicillinAmoxicillin
    0143-9888AmoxicillinAmoxicillin
    68071-1675AmoxicillinAmoxicillin
    68071-1760AmoxicillinAmoxicillin
    68071-1817AmoxicillinAmoxicillin
    68071-1526AmoxicillinAmoxicillin
    68071-1761AmoxicillinAmoxicillin
    68071-1789AmoxicillinAmoxicillin
    68071-3292AmoxicillinAmoxicillin
    68071-3339AmoxicillinAmoxicillin
    68071-3343AmoxicillinAmoxicillin
    68071-3235AmoxicillinAmoxicillin
    68071-4086AmoxicillinAmoxicillin
    68071-3119AmoxicillinAmoxicillin
    68071-4064AmoxicillinAmoxicillin
    68071-4192AmoxicillinAmoxicillin
    68071-4079AmoxicillinAmoxicillin
    68071-4189AmoxicillinAmoxicillin
    68071-4468AmoxicillinAmoxicillin
    68071-4548AmoxicillinAmoxicillin
    68071-4338AmoxicillinAmoxicillin
    68071-4455AmoxicillinAmoxicillin
    68071-4196AmoxicillinAmoxicillin
    68071-4693AmoxicillinAmoxicillin
    68071-4418AmoxicillinAmoxicillin
    68071-4724AmoxicillinAmoxicillin
    68071-4581AmoxicillinAmoxicillin
    68071-4574AmoxicillinAmoxicillin
    68071-4567AmoxicillinAmoxicillin
    68071-4734AmoxicillinAmoxicillin
    68071-4796AmoxicillinAmoxicillin
    68071-4696AmoxicillinAmoxicillin
    68071-4698AmoxicillinAmoxicillin
    68071-4741AmoxicillinAmoxicillin
    68071-4704AmoxicillinAmoxicillin
    0440-7100AmoxicillinAmoxicillin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.